Collapsible ampul syringe



' E. H. MARcY GOLLAPSIBLE AIPUL SYRINGE 'Filed April 17, 1924 Y 4 fr 56%ff zr W reaction.

Patented Oct. 16, 1928.

l UNITED ASTATES ERNEST H. MARCY, 0F BELMONT, MASSACHUSETTS.

(JOLIiitJSIBLEl AMPUL SYRINGE.

Application l'ed April" 17, 1924. "Seria-1 No. 707,295. y

The present invention relates -to instruments for hypodermicallyadministering medicines and other liquids; that is instruments whichinclude a tubular needle as the means for conducting the liquid into theveins or tissues ofthe patient. Themain object of the invention is toenable the medicine to be directly administeredfrom a sterile originalpackage or container, and without need of placing the original packagein a'syringe, or in association with any other device except1 in someeases only, a hypodermic needle. vThe accomplishment of this objectinvolves making the container of flexible andcollapsible construction,which in itself is not Anew with the present invention; but theaccomplishrnent ofthe further object of delivering the medicine to theuser in an assuredly sterile or uncontaminated condition is a newresult.

While hypodermic units including collapsible medicine containers haverecently gone into extensive use and met with wide favor, suchcontainers as have heretofore been used are subject to one great andserious defect, namely, that they cannot be sterilized. Therefore evenin spite of the greatest care to see that before filling the containersare clean and that pure and clean solutions are put into them, yet theimpossibility of sterilizing them after filling, or of insuring thatthey will remain intact from penetration of harmful micro-organisms, hasmade impossible any assurance that at the time of use, the containedmedicine will be perfectly safe to use. By the present invention theelement of lack of perfect safety has been `removed and I-have now madeit possible to put up at the manufacturing laboratory a sterile solutionin a container from which the solution may be .injected h ypodermicallywithout transfer to another instrument. and with which assurance may begiven that the.sol ution is sterile and will rem-ain so until time ofuse, however long deferred. provided the solution is not one 'of thosewhich is liable to change by internal In this specification I use theword sterile and words of similar import in a genericsense to indicatethat condition inwhich the medicine is free from harmful foreignmatter.' By the use of these terms I do not mean merely -that thesolution has been made sterile by destruction of all organisms therein,but I intend to include also that condition of such solutions asbiological products in which the products, while containingorganic life,are

` yet free from, deleterious organisms.

A f urther object is to furnish an improved, simplified, and inexpensiveneedle and needle protector, in association with a sealed ampul ofcollapsible character. v

The invention consists in a collapsible am' pul of the characterindicated and in the combination and association therewith ofcooperating parts and elements, as above indicated, and as moreparticularly pointed out in the following specification and claims.

In the drawings:

Figure 1 lis a longitudinal section of va hypodermic ampul unitembodying my present invention, filled and in the condition in vwhich itis furnished to users.

Fig. 2 is asimilar View of the unit after the same hasbeen made readyfor use by putting the needle into connection with the contents of theanipul.

Fig. 3 is a sectional view of the ampul before filling;

Figs 4 and 5 are detached perspective views of the parts of my ampulneedle sheath or protector, the member shown in Fig. 5,being partlybroken away.;

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Fig. 6 is a detail sectional view enlarged of a` sealing element adaptedto be used with such ampul;

Fig. 7 is a perspective view enlarged, of the new form of hypodermicneedle which I have applied tothe unit shown ,in Figs. 1 and 2;

Fig. 8 is a side view of a filled and sterilized ampul embodying theinvention and adapted to beused with a separate needle;

Fig. 9 is asectional View of a hypodermic needle designed and adapted tobe used repeatedly in combination with ampules of the soi-t shown in thepreceding figures;

Fig. 10 is a sectional view of an ampul unit similar to that shown inFigs. l and 2, but combined with a specifically different needle andprotective sheath;

Figs. 11 and 1-2 are perspective views of the needle and sheath,respectively, shown in Fig. 10. f

Like reference4 characters designate the same parts wherever they occurin all the figures. v

Referring first to Fig. 3 which shows in detail Athe container which isadapted to be filled with medicine I'the same consists of a body orshell 15 having at one end a tubular neck 16. This bodyr is made of amaterial may be used, and as an example of a non! metallic substance, Imay mention huguloid, which is a special preparation of nitro cellulose.These materials are mentioned as illustrat-ive of many which might beused, and

- also as those which are best suited for the purpose, but not as an`exhaustive catalogue of all that might be used; The neck 16 ispreferably cylindrical and of uniform diameter in order that it mayreceive, in a sli-ding manner, and be resiliently grasped by, theprotecting cap presently described, or the hub or sleeve of a hypodermicneedle. It is also preferably of smaller diameter or width than the bodand is joined to the latter by a shoulder l?.

In carrying out my purpose of making an ampul which can be sterilized, Iform within the neck 16 an integral partition 18, and I close theopposite end of the shell at 19. The closed end is sealed in such a waythat no opening however minute is left through which air and'micro-organisms may enter or through which the contained solution mayescape; and the seal is also strong enough to sustain a substantialinternal pressure, that is, the pressure generated by heating theconfined solution to the degree and in the manner of any approved methodof sterilization. I prefer to form this sealed'closure of the shell bypinching its walls together at the end opposite to that across which thepartition lies, and uniting the contiguous parts of such walls insubstantially integral union. Such union may be effected inl a varietyof ways, as by fusion, electro-deposition of metal, or the use of asolvent which will so affect the contiguous walls as to cause them tocoalesce. Within the scope of union by fusion; I include that induced byheat (applicable by electric welding electrodes, a hot iron or wire, 'aconcentrated fiame,etc.) sufiiciently intense and localized to causemelting together of the parts affected, with or without aid from a flux,and that effected b soldering or the like, as well. lAn ampulliermetically sealed by any of the means above indicated, or by otherpossible means as well. is within the scope of my claims for an ampulhermetically sealed, or sealed by integral union of its enclosing walls.

While the ampul may be filled through its open end before the latter isclosed and sealed, it may, and lin some instances should, be filledafter closing the end; and in order that it may be so filled, there maybe left; at some point in the shell, preferably in the shoulder 17,a-small opening 20 surrounded by a lip or fiange 21. This opening islarge enough to admit a filling tube of a size comparable to that of ahypodermic needle. The container so made is ready for reception of itscharge of medicine, and is completely closed by the substantiallyintegral continuity of all its walls, except for the filling opening 20.The medicinal charge is introduced into the shell through this openingby means of a tube small enough to enter it, and when filled the openingis closed and sealed by fusion, or in the other ways above indicated.rIhe lip or flange 21 which surrounds the opening aids in thus closingand sealing it as it furnishes an excess of material which will melt andfiow together across the hole when affected by sufficiently intenseconcen trated heat. Heat of this character may feasibly be applied by anincandescent wire or by electric spot'welding. The trace of the holethus closed is shown at 2ln in Figs. 1, 2, 3,8 and 10. Thus when filledand sealed as described, the ampul has a completely integral envelope,without any openings through which the contained solution may escape orthrough which organisms may enter and having strength sufficient tosustain without rupture the pressure generated in the con? finedsolution by heat great enough to dastroy all organisms.

The partition 18 is located back from the mouth of the neck 16, and thusleaves within the neck a space 2:2 adapted to contain a packing memberwhich will occupy the space between the walls of the neck and aninserted hypodermic needle and prevent leakage around the needle whenthe ampul is discharged. Such packing member may be variously made andof various materials, as for example a plastic material poured or forcedinto the space 2Q. when in liquid or semi-liquid condition. and of suchnature it will be solid at sterilizing, and lower, tem

peratures, but is penetrable by a hypodermic needle. However I prefer touse a plug of solid and substantially infusible, but penetrable andresilient material. A plug Q3 made of vulcanized rubber composition andmolded in the form shown in Fig. 6, is eininently suitable for thepurpose. It is preferably retained, and may be put under coinpression,in the space 22 by spinning or compressing the edge of the neck partlyover its end. Then it is confined between the partition 18, which servesas a supporting ledge for the plug within the neck, and the inturnedlip24.- on the end ofthe neck, such lip being for that purpose aretaining flange. This plug not only seals the needle, as stated, but italso grasps inner end portion of the needle, holding it in place beforeuse and prefill venting its separation from the ampul dur- A "as bycompressing and so binding it upon the needle, or by soldering orequivalent means. This needle is combined with the ampul and with aprotective sheath tp make a complete unit, one end of the needle beingpassed part way through the plug 23, but to a point short of thepartition 18 and of the inner endl of the plug; that is a positionsubstantially as shown in Figure 1. I

The preferred form of sheath is made of i two vparts 27 and v 28, thepart 27 being a vtube closedfat one end and open at the other end, theopen end providing a shoulder 29 of smaller diameter than the needleshoulder or abutment 26, whereby it is adapted to bear on the latter andtransmit pressure thereto endwise of the needle. The part 28 is asleeve, slotted throughout its length atv one side,

4vwhereby it is made springy and thereby `enabled to grasp resilientlyboth the ampul neck-and the tube part27. It should be nted` that, inorder for the/sleeve to do this most eifectively, the member 27 shouldbe approximately the same inI external diameter as the ampul neck 16.The sleeve member 28 can be very economically made by rolling a flatblank of suitable metal into tubular form and to a. diameter slightlyless than that of the neck and of the tube 27, so that it will be spreadwhen slipped over these" parts.

Thusit grips both parts resiliently and firmly enough to hol'd the'tubular part 27 in place, but permits the tubular part to be readilymoved endwise within the sleeve. The sleeve,

being. thus held and bearing against the shoulder vof the needle, holdsthe latter in place also, and the needle is additionally held by thepressure rof the resilient envelopingA plug on its inner end part.Preferably an dust and harmful enveloping mass of fibrous material.suchl as surgeons gauze. in sterile condition isr` placed in the sheathso-as to envelop the outer part of the'needleand excludefmoisture,

micro-organisms therefrom. i D

The complete unit, consisting of the filled and sealed ampul, theneedle, and the sheath associated substantially as shown in Figure 1 isfurnished to users ready for use. In this condition the end 'of thesheath member 27 protrudes from theend of the`sleeve member 28 by adistance at least as great as the -movement of the needle necessary topass its inner point through the partition 18 and place its bore `incommunication with vthe contents of the ampul ;A and the distance of thebutton 26 from the end of the ampul neck is also at least as great asthe same distance. It is made ready for use by pushing the needle in-'ward until its inner point punctures the partition 18 and passestherethrough far v enough to bring the open bore of theneedle inside ofthe partition. Pressure for this purpose is applied to the protrudingend of thel sheath member 27, this member sliding easily in the sleevemember 28 and pushing the needle shoulder 26 before it.` The unit is nowin the condition shown in Figure 2. Finally the sheath is grasped by thesleeve portion and pulled off from the ampul, leaving the needle exposedready to be passed into the ,tissues of the patient. The needle does notfollow the sheath when the latter is thus removed, because its innerpart4 is grasped more tightly by the enveloping plug f than the outerpart is grasped by theloose fibrous mass 30; and the grip of the plugupon the needle is also strong enough to pull it out of the musculartissue after an injection has, been performed. The compressed state inwhich the plug may be put by turning in the lip at the end of the ampulneck, as hereinbefore described, makes it possible to secure as firm agri on the needle by means of the plug as may e needed for any purpose.

A specifically different' construction of needle, or ratherassociation'of needle and means for holding and moving it, is shown inFigures 10, 11 and 12. In this fom the needle is associated with a cap81 having a closed end and an open end. The closed end provides a Wallthrough which the needle passes and to which it is secured., The openend is adapted to surround and slide upon the neck of the ampul body. Inorder thatit may it ir/mly and at the same time slide freely on saidneck, this cap is slotted for a certain distance from its open end,whereby its Walls adjacent to the open end are converted into springtongues or jaws.

When the ampul unitv is put vout as such,

abutting against the shoulder. Hence the needle can be passed throughthe partition so as to open a passage ,for `discharge of themedicine,.by sliding the cap down orinward on the 'neck of the ampul.

This unitalso is completed as an `article of commerce by a4 sheath,which may be thev same as the one already described, b ut I have chosento show here a modified form of sheath containing in principle many ofthev features of the other sheath, and capable of being used in place ofthat one upon the unit first described. The modified sheath 2"(a is madeall in one piece, adapted to slip over the cap of the needle at its openend, and there formed with spring jaws by notches 32, so that it may beretained in place by grasping the sleeve by means of such spring jaws.

shoulder 29a, adapted to apply pressure to i the said cap in moving itto force the inner point of the needle through the partition 18, isformed by indenting a zone of the sheath at a suitable distance fromitsv open end, substantially as shown. 30, or equivalent material toenvelop and protect the needle, may be used here also.

The end of the cap then serves as a shoulder.

sential to the coupling of the needle with its interior in the mannerset forth, is that the partition must be penetrable by the inner pointof the needle. This condition is readily satisfied by making the ampuland its integral partition of tin, or of other materials indicated, andfurther, by making the partition thin enough. I have found in practicethat it is readily lfeasible to make the partition with thesecharacteristics in ampules produced on a commercial scale.

The parts of the unit thus described may be sterilized separatelv andassembled, or may be assembled first and then sterilized. f Preferablythey are first assembled in the condi- .y tion indicated by Figures 1and 10. Sterilization of the units thus assembled may be effected by anyof the means or methods used by the medical profession and manufacturingchemists, without danger to the integrity of the ampul or its contents.When the unit leaves the laboratory it is sterile, and both thecontained medicine and the needle are protected from subsequentcontamination in any manner, since no septic matter can reach either themedicine or that part of the needle which is passed under the skin, ofthe patient. Thus the unit may be safely used at any time, no matter howlong, after being put up, subject only to the time limitation due to thenature of the medicine itself, as in the case of medicines whichdeteriorate or change their com`- position with age.y Even in the act ofbringing the needle into connection with the medicine, there is noliability of contaminating the Sterile gauze Y successively to a numberof ampules.

needle, because the pressure for thus moving the needle is applied tothe sheath, which is then removed. The operator need not touch theyneedle or even put his fingers in a position where there is danger oftouching it before passing it into the patient. That part of the Vneedlewhich lies ust outside of the plug does not need protection because itnever comes into Contact with the medicine, but is closely enveloped bythe plug when the needle is pushed home.'

Ampules having the capacity of sterilization, and being sterile, asherein pointed out, may also be furnished Without the additionalequipment of needle and sheath which makesl the complete unit, butadapted to be used with a separate needle, which latter can be appliedThis ampul is constructed, filled, sealed and sterilized substantiallyas described. The space within the outer part of its neck is providedwith a packing medium, and the neck is protected by a cap 33. This capis slipped over the neck of the ampul in the same manner as the needlecap 31, and it may be made of any suitable material, but the material ispreferably a nitro-cellulose compound of the sort previously described,the same being inexpensive and therefore such that it can be'thrownaway.

The needle used with a succession of ampules has the samecharacteristics as the second one previously described, and in additionis equipped with an outer cap 34 of such strong and rugged constructionthat it can be squeezed and otherwise roughly handled without beingdeformed. It encloses the spring tongues of the inner cap 31 andprotects the latter from deformation by the pressure which the operatorunavoidably exerts with his fingers in putting the needle on the ampuland removing it, but it does not confine these'tongues .closely enoughto impair in anyway their function of resiliently gripping the neck ofthe ampul. It is effectively made fast to the closed end of the innercap or to the needle, or both, in any suitable way.

The ampul of this invention combines for the first time thefqualities ofcollapsibility and capacity for sterilization by heat. Heretofore theonly ampules which could thus be sterilized and could be relied on tomaintain their contents in sterile condition, have been those made ofglass. But in order to discharge a glass ampul hypodermically, it isnecessary either to transfer the contents firstto a hypodermic syringe,or to apply some form of external expelling device, such as a piston orpusher, as w'ell as a hypodermic needle, to the ampul. My ampul may bedischarged directly into the tissues ior veins of a patient by merelysqueezing it.

On the other hand although hypodermic instruments have been used ofwhich the medicine container is collapsible, these conlll) tainers havenot beenfcapable of eicient and safe sterilizatioknmhen filled, nor havethey been secured against possible contamination' tion consists not onlyof the entire combina-` tion involved. in the ampul. unit hereinbeforedescribed, but includes also the novel features of the several elementsof the combination alone, and without limitation by the novel featuresof other elements. For example, while the hermetically .sealed ammilhaving substantially integral continuity of its enclosing wallsthroughout, is an important feature of the invention, nevertheless Iclaim protection for the novel features of the needle` the sheath, etc.,as devices adapted to be used with ampules or other character as Well asthat particularly specified.

`What I claim and desire to secure by Letters Patent is 1. An ampulcomprising an elongatedvcollapsible shell'having an integrfl penetrableclosing wall at one end and being there adapted for connection with ahypodermic needle, and its walls at the other end being integrallyjoined together, said shell having between its4 ends a filling openingadapted to be integrally sealed after filling.

2. A hypodermic ampul unit comprising a collapsible ampul having a neckwith an in-l ternal transverse partition, a resilient penetrable plug insaid neck outside of the partition, a double pointed needle enteringsaid plug and extending toward said partition and having fapressure-receiving shoulder at a distance from the end of the neck, anda sheath enclosing the outer part of the needle and formed with aIshoulder arranged to bear on said needle shoulder, said sheath having aportion embracing the neck and being adapted to slide endwise thereon.

3. A hypodermic unit comprisingpa coli lapsible ampul, a hypodermicneedle and a sheath, an ampul having an integral stopping means in oneend of a character adapted to.

be penetrated by a hypodermic 4needle and its walls being joined inintegral continuity throughout the needle having points at both endsadapted to penetrate Isaid stopping means and having also an abutmentbetween its ends, and the sheath having a separable mounting on the endof the ampul whereby it embraces the needle when the latter is in linewith the penetrably closed portion of the ampul, and said sheath havingan internal shoulder portion adapted to engage said needle abutment,and, by applying pressure thereto force the inner point of the needlethrough said closing means. 4

4c. The combination with a double pointed hypodermic needle having anexternalshoulder between its ends, of a needle sheath con taining a massof fibrous materialin which the inserted needle is enveloped, saidsheath including an internal shoulder arranged to engage and impartmotion by pressure application to the shoulder of the needle, and havingfurther an open end adapted to embrace the neck of an ampul.

In testimony whereof I have affixed my signature.

ERNEST I-I. MARCY.

